Endoscopic apparatus having an outer rail

ABSTRACT

An endoscope apparatus for endoscopic treatment is disclosed. The apparatus comprises an endoscopic insertion tube comprising an outer surface including an outer rail formed longitudinally thereon and extending along a portion of the insertion tube. The outer rail has a predetermined shape. The insertion tube comprises an inner channel formed therethrough. An endoscope apparatus for endoscopic treatment is disclosed. The apparatus comprises an endoscopic insertion tube without a working channel and an outer surface including at least one outer rail formed longitudinally thereon and extending along a portion of the insertion tube. The outer rail has a first predetermined shape. At least one medical device includes an outer wall having at least one mounting unit formed thereon along a portion of the length of the outer wall. The mounting unit has a second predetermined shape cooperable with the first predetermined shape. The second predetermined shape is formed to complement and slidably cooperate with the first predetermined shape of the outer rail for slidably attaching the medical device thereto.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser.No. 60/921,386, filed on Apr. 2, 2007, entitled “ENDOSCOPIC APPARATUSHAVING AN OUTER RAIL,” the entire contents of which are incorporatedherein by reference.

BACKGROUND OF THE INVENTION

The present invention relates to endoscopic apparatus having outer railguide systems.

Endoscopic devices have been commonly used for various procedures,typically in the abdominal area. Endoscopy is the examination andinspection of the interior of body organs, joints or cavities through anendoscope. Endoscopy allows physicians to peer through the body'spassageways. An endoscopic procedure may be used to diagnose variousconditions by close examination of internal organ and body structuresand may also guide therapy and repair, such as the removal of torncartilage from the bearing surfaces of a joint. A biopsy, a procedureinvolving tissue sampling for pathologic testing, may also be performedunder endoscopic guidance. For example, endoscopic procedures includethe following known procedures: gastroscopy, sigmoidoscopy andcolonoscopy, esophago gastro duodenoscopy (EGD), endoscopic retrogradecholangiopancreatography (ERCP), and bronchoscopy.

An endoscope typically includes at least one separate port or workingchannel. Such port(s) may be used to introduce endoscopic instrumentssuch as catheters, forceps, scissors, brushes, snares or baskets fortissue excision, sampling, or other diagnostic and therapeutic work. Theinner diameter of such working channels or ports may vary based on theinstruments used during an endoscopic procedure, affecting the overallouter diameter size of the insertion tube of the endoscope. Thedifferences in diameter typically affect the resulting size of the outerdiameter of the endoscope. Moreover, as clinicians may use a number ofvarious sized medical devices during an endoscopic procedure, they facechallenges in maintaining wire guide position in certain anatomy, e.g.,within the biliary tree, while executing an endoscopic procedure.

Thus, it is desirable to provide an improved endoscope apparatus thatallows a clinician the ability to use various sizes of medical deviceswith one endoscope while maintaining longitudinal positioning within apatient's gastrointestinal anatomy.

BRIEF SUMMARY OF THE INVENTION

The present invention generally provides an outer rail endoscopicapparatus including an outer rail guide system that allows a clinicianthe ability to use various sizes of medical devices with one endoscopewhile maintaining longitudinal positioning within a patient'sgastrointestinal anatomy.

In one embodiment, the present invention provides an endoscope apparatusfor endoscopic treatment. The apparatus comprises an endoscopicinsertion tube comprising an outer surface including an outer railformed longitudinally thereon and extending along a portion of theinsertion tube. The outer rail has a predetermined shape. The insertiontube comprises an inner channel formed therethrough. An endoscopeapparatus for endoscopic treatment is disclosed. The apparatus comprisesan endoscopic insertion tube without a working channel and an outersurface including at least one outer rail formed longitudinally thereonand extending along a portion of the insertion tube. The outer rail hasa first predetermined shape. At least one medical device includes anouter wall having at least one mounting unit formed thereon along aportion of the length of the outer wall. The mounting unit has a secondpredetermined shape cooperable with the first predetermined shape. Thesecond predetermined shape is formed to complement and slidablycooperate with the first predetermined shape of the outer rail forslidably attaching the medical device thereto.

In another embodiment, the present invention provides an endoscopicapparatus having an outer rail system for endoscopic treatment. Theapparatus comprises the endoscopic apparatus and at least one medicaldevice including an outer wall having at least one mounting unit formedthereon along the length of the outer wall. The mounting unit isconfigured to slidably mate with the outer rail of the insertion tubefor attaching the medical device thereto.

In yet another example, the present invention provides a method of usingan endoscopic apparatus having an outer rail system for endoscopictreatment. The method comprises introducing the endoscopic apparatus inthe gastrointestinal tract of a patient to an interventional locationtherein. The method further comprises maintaining position of theapparatus at the interventional location and introducing the medicaldevice through the proximal end of the insertion tube. The methodfurther comprises advancing the medical device beyond the distal end ofthe insertion tube for enhanced endoscopic treatment.

Further objects, features, and advantages of the present invention willbecome apparent from consideration of the following description and theappended claims when taken in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an elevated view of an outer rail endoscopic apparatus inaccordance with one embodiment of the present invention;

FIG. 1B is a side view of the insertion tube of the apparatus of FIG.1A;

FIG. 1C is a partial view of the insertion tube of the endoscopicapparatus of FIG. 1A;

FIG. 1D is a perspective view of a medical device that cooperates withthe insertion tube of the endoscopic apparatus of FIG. 1A;

FIG. 2 is a partial exploded view of the apparatus of FIG. 1A;

FIG. 3A is an end view of the apparatus of FIG. 1A;

FIG. 3B is a cross-sectional view of the apparatus of 1A taken alongline 3B-3B;

FIG. 3C is a cross-sectional view of the apparatus of 1A taken alongline 3C-3C;

FIG. 3D is a cross-sectional view of the apparatus of 1A taken alongline 3D-3D;

FIG. 4 is a partial view of the apparatus of FIG. 1A;

FIG. 5 is an end view of the apparatus of FIG. 4;

FIG. 6 is an end view of the apparatus in accordance with anotherembodiment of the present invention;

FIG. 7 is an end view of an apparatus in accordance with yet anotherembodiment of the present invention; and

FIG. 8 is a flow chart of one method of using the endoscopic apparatusof FIG. 1 in accordance with one example of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention generally provides an outer rail endoscopicapparatus that allows a clinician the ability to use various sizes ofmedical devices with one endoscope while maintaining longitudinalpositioning within a patient's gastrointestinal anatomy. This featurealso allows for a smaller or relatively reduced diametric size of theinsertion tube. The reduced diameter of the insertion tube allows theclinician to be able to more easily perform an endoscopic treatmentwithin a patient's anatomy (e.g., within the biliary duct) thatotherwise would not be possible or would be a relatively high riskprocedure. Each of the embodiments of the present invention comprises aninsertion tube having an outer surface with an outer rail. Each outerrail is configured to cooperate with a mounting unit formed on a medicaldevice (e.g., a wire guide or catheter) to be used during the endoscopictreatment. The medical device is slidably attachable to the side of theinsertion tube at its proximal end and is distally advanced beyond thedistal end of the insertion tube. This aspect allows enhancedpositioning and treatment in areas of the anatomy otherwiseunobtainable. Additionally, scope repairs would be reduced as the scopewould not have to be sent out for repairs to the accessory channel.

FIG. 1A illustrates an endoscopic apparatus 10 having an outer railsystem for enhanced endoscopic treatment in accordance with oneembodiment of the present invention. As shown, the endoscopic apparatus10 comprises a flexible insertion tube 12 and a control system 13 incommunication with the insertion tube 12. As shown in FIGS. 1A and 1B,the flexible insertion tube 12 comprises an outer surface 14 includingat least one outer rail 20 formed thereon. Preferably, the outer rail 20comprises a first predetermined portion or shape 22 (discussed ingreater detail below) to accommodate a complementary shape for attachinga medical device 24 thereto. In this embodiment, the outer rail 20 isformed on the outer surface 14 along the length of the insertion tube12.

The outer rail 20 is formed on the outer surface 14 of the insertiontube 12 and replaces a conventional endoscopic working channel typicallyformed through the insertion tube 12 of an endoscope, thereby defining asmaller or reduced diametric size of the insertion tube 12. The outerrail 20 is configured to allow a medical device 24, e.g., a wire guide,to be slidably interlocked therewith and advanced relative to theinsertion tube 12. The first predetermined shape 22 of the outer rail 20may take on any suitable shape that allows a complementary orcooperating shape to be able to slide through and lock itself thereon.For example, as shown in FIGS. 2-5, the outer rail 20 of the insertiontube 12 is an interlocking rack that is configured to interlock with acomplementing or cooperating shape formed along the length of a medicaldevice 24, e.g., a wire guide or catheter. The medical device 24 may bedistally advanced beyond the distal end of the insertion tube 12 toreach areas of an anatomy otherwise unobtainable by a conventionalendoscope.

As mentioned above, the outer rail 20 replaces a conventional endoscopicworking channel typically formed through the insertion tube 12. Asshown, the insertion tube 12 does not have a conventional endoscopicworking channel. Rather, the insertion tube 12 comprises at least oneinner channel in which endoscopic components are disposed, defining areduced outer diameter occupied by the insertion tube 12. In thisembodiment, the endoscopic components vary depending on the purpose ofuse for the endoscope. For example, the apparatus 10 includes any numberof inner channels. In this embodiment, there are three inner channelsshown in FIGS. 1A-5. As shown, an illumination channel 32 is formedthrough the insertion tube 12 through which a fiberoptic cable isinserted for the transmission of light from a light source. Moreover, aviewing channel 34 can also be provided with a fiberoptic cable forviewing purposes and a fluid channel 36 can be provided for applicationof suction at the surgical site. In another example, the inner channelmay be a fluid channel, a light channel, and a camera channel formedthrough the insertion tube to allow for fluid, light, and a camera,respectively therethrough.

The endoscopic apparatus 10 shown in FIG. 1A further comprises a controlsystem 13 in mechanical and fluid communication with the insertion tube12. The control system 13 is configured to control at least one of theendoscopic components. It is to be understood that any other suitableendoscopic operating control system 13 may be used with the insertiontube 12 described above without falling beyond the scope or spirit ofthe present invention. In one embodiment, the control system 13 includesan auxiliary port portion 123 having a proximal opening 124. The fluidchannel 36 extends into the auxiliary port 123 by way of a fluid channelextension 119 a. Each of the channels preferably opens at the distal orinsertion end 113 of the flexible section 12 of the endoscopic apparatus10.

The control system 13 of the endoscopic apparatus 10 shown in FIG. 1Acan be of many different types so long as it is in fluid and mechanicalcommunication with the inner channels formed through the insertion tube12 of the endoscopic apparatus 10. While most of the working componentsof these control systems 13 are similar, each may have a differentconfiguration without falling beyond the scope or spirit of the presentinvention. For example, the proximal opening and the auxiliary port maydiffer amongst each other. Each of these specifically identified controlsystems, and other commercially available endoscopes, utilize differentsealing members (not shown) at the proximal opening of the auxiliaryport. It is understood that the various aspects of the present inventionaccommodate the secure attachment to various configurations anddimensions of a variety of endoscopes.

As shown, the endoscopic apparatus 10 further comprises at least onemedical device 24 having an outer wall 42 comprising at least onemounting unit 44 formed thereon along the length of the outer wall 42.In this embodiment, the mounting unit 44 is configured to slidably matewith the outer rail 20 of the insertion tube 12 for slidably attachingthe medical device 24 thereto. Preferably, the mounting unit 44 has asecond predetermined portion or shape 46 cooperable with the firstpredetermined shape 22. The second predetermined shape 46 is formed tocomplement and slidably cooperate with the first predetermined shape 22of the outer rail 20 for slidably attaching the medical device thereto.

In this example, this is accomplished by having the second predeterminedshape 46 take on a complementing shape relative to the firstpredetermined shape 22. As shown in FIGS. 2-5, the medical device 24slidably interlocks with the insertion tube 12 due to the cooperatingrelationship between the outer rail 20 and the mounting unit 44.

In this example, the outer rail 20 is configured to proximally taper ordistally flare longitudinally along the outer surface 14 of theinsertion tube 12 to receive the mounting unit 44. As shown in FIGS. 1A,2, and 3A-D, the mounting unit 44 is slidably received by the outer rail20 at a proximal portion of the insertion tube 12. The mounting unit 44extends distally along the insertion tube 12. Although not necessarily,the mounting unit 44 may extend to the distal end of the insertion tube12 or may end proximal thereto (see FIGS. 1B-D). Moreover, in thisembodiment, the mounting unit 44 extends proximally to a hub 45 throughwhich other devices may be introduced through the endoscope.

As shown in FIG. 1C, in one example, each of the outer rails 20 isformed longitudinally along the outer surface 14 of the insertion tube12. Preferably, each of the outer rails 20 extends distally on the outersurface 14 to the distal end 113 of the insertion tube 12. In thisembodiment, the outer rail 20 is formed with increased prominencedistally along the outer surface, having an increased area or depthbetween each adjacent outer rail 20 at the distal end 113. This allowsthe mounting unit 44 (see FIG. 1D) to slidably cooperate with the outersurface 14 and attach the medical device 24 to the insertion tube 12.

It is to be understood that each of the outer rails 20 and mountingunits 44 may take on any suitable shape. This is possible so long aseach outer rail 20 and its corresponding mounting unit 44 are configuredto complement each other such that when engaged with each other in aslidably cooperating relationship, the two units are slidablyinterlocked with each other. Furthermore, depending on the number ofouter rails 20 formed on the insertion tube 12, the same number ofmedical devices 40 may be used with the insertion tube 12 during anendoscopic procedure.

In this embodiment, the insertion tube 12 comprises a proximal end 111and a distal end 113. Preferably, each outer rail 20 is formed on theinsertion tube 12 from the proximal end 111 to the distal end 113 sothat the medical device 24 may be slidably introduced at the proximalend 111 and advanced beyond the distal end 113. This may be accomplishedby any suitable manner, e.g., by having a tapered formation of the firstpredetermined shape 22 near the proximal end of the insertion tube 12.The medical device may then be introduced and advanced at the taperedformation to slidably engage the insertion tube 12. In use, e.g., acatheter, may be advanced to a location beyond the distal end of theinsertion tube 12 to a stricture within the anatomy otherwiseunobtainable with the outer diameter size of a conventional endoscope.

It is to be noted that the outer rail formed on the insertion tube maysimply be one outer rail or a plurality thereof. In the embodiment shownin FIGS. 1 a-5, the insertion tube comprises one outer rail formed alongthe length of the insertion tube. However, the embodiment provided inFIG. 6 includes four outer rails 220. As shown, the insertion tube 212comprises four outer rails 220 having first predetermined shapesradially formed about the outer surface of the insertion tube. In thisembodiment, each of the outer rails 220 has a first predetermined shapethat is the same as the others. As shown, the apparatus comprises anillumination channel 216 through which a fiberoptic cable is insertedfor the transmission of light from a light source. Moreover, theapparatus comprises a viewing channel 217 having a fiberoptic cable forviewing purposes and a third channel 218 for application of fluid orsuction at the surgical site. A corresponding mounting unit having asecond predetermined shape of a medical device (not shown) may be usedto slidably attach to the outer rail in the similar manner as describedabove. Thus, a series of accessory channels would be able to engage theouter rail. This would allow the user flexibility during the procedurebecause the channel could be interchanged or swapped as desired.

The embodiment provided in FIG. 7 includes two outer rails 320 formed onthe insertion tube 312, each of which having a first predetermined shapethat is the same as the other. A corresponding mounting unit has asecond predetermined shape that may be used to slidably attach to theouter rail in the similar manner as described above. Thus, a series ofaccessory channels would be able to engage the outer rail. This wouldallow the user flexibility during the procedure because the channelcould be interchanged or swapped as desired. In this embodiment, theapparatus also includes inner channels similar to the inner channelsmentioned above.

FIG. 8 illustrates a flow chart of one method 410 of using theendoscopic apparatus discussed above having an outer rail system forendoscopic treatment. As shown, the method comprises introducing theendoscopic apparatus in the gastrointestinal tract of a patient to aninterventional location therein in box 412 and maintaining position ofthe apparatus at the interventional location in box 414. The method 410further includes introducing a medical device through the proximal endof the insertion tube. The mounting unit is configured to slidably matewith the outer rail of the insertion tube for attaching a medical devicethereto. In this example, this may be accomplished by having the outerrail formed on the outer surface at a proximal portion of the insertiontube. The outer rail may be formed to proximally taper or distally flareto receive the mounting unit which may be slidably attached therewith.The mounting unit may extend proximally from the insertion tube to aport through which a medical device may be disposed for introductionthereof into the patient.

The method 410 further comprises advancing the medical device beyond thedistal end of the insertion tube for enhanced endoscopic treatment thatallows a clinician the ability to use various sizes of medical deviceswith one endoscope while maintaining longitudinal positioning within apatient's gastrointestinal anatomy in box 416.

The medical device is preferably provided separately from the endoscopicapparatus with the outer rail(s) already formed along the outer surfaceof the insertion tube. At a desired time during the use of the flexibleinsertion tube, the medical device can be slidably engaged along thelength of the outer surface of the insertion tube. The medical devicemay be introduced at the proximal end thereof and then may be slidablyadvanced beyond the distal end of the insertion tube to a desiredlocation within the anatomy of a patient. Additionally, scope repairswould be reduced as the scope would not have to be sent out for repairsto the accessory channel.

While the present invention has been described in terms of preferredembodiments, it will be understood, of course, that the invention is notlimited thereto since modifications may be made to those skilled in theart, particularly in light of the foregoing teachings.

The invention claimed is:
 1. An endoscope apparatus for endoscopictreatment, the apparatus comprising: an endoscopic insertion tube havinga proximal end and extending to a distal end, the endoscopic insertiontube having at least one illumination channel and at least one viewingchannel and not having a working channel capable of introducing anendoscopic instrument therethrough, and comprising an outer surfaceformed into at least one outer rail having an outer rail length, theouter rail formed longitudinally and extending from a proximal portionof the insertion tube to the distal end of the insertion tube, the outerrail having a first predetermined shape; at least one medical deviceincluding an outer wall having at least one mounting unit formed thereonalong a portion of a length of the outer wall, the mounting unit havinga second predetermined shape cooperable with the first predeterminedshape; the second predetermined shape formed to complement and slidablycooperate with the first predetermined shape of the outer rail forslidably attaching the medical device thereto; and wherein each outerrail is formed with increased prominence along the outer rail lengthfrom the proximal portion to the distal end, a diameter of the at leastone outer rail comprising the outer surface of the endoscopic insertiontube proximally and gradually decreasing longitudinally to receive themounting unit.
 2. The apparatus of claim 1 wherein the at least oneouter rail comprises first and second outer rails formed on the outersurface.
 3. The apparatus of claim 2 wherein the at least one medicaldevice comprises first and second medical devices, each having mountingunits formed thereon and configured to mate with one of the first andsecond outer rails.
 4. The apparatus of claim 1 wherein the insertiontube comprises a proximal end and a distal end, the at least one outerrail being formed on the insertion tube from the proximal end to thedistal end so that the medical device may be slidably introduced at theproximal end and advanced beyond the distal end.
 5. The apparatus ofclaim 1 wherein the first predetermined shape has two grooves, thesecond predetermined shape being cooperable with the two grooves of thefirst predetermined shape.
 6. The apparatus of claim 1 wherein the atleast one mounting unit proximally tapers longitudinally along the outerwall of the at least one medical device to engage the outer rail.
 7. Theapparatus of claim 3 wherein the at least one mounting unit proximallytapers longitudinally along the outer wall of the at least one medicaldevice to engage the outer rail.
 8. The apparatus of claim 4 wherein theat least one mounting unit proximally tapers longitudinally along theouter wall of the at least one medical device to engage the outer rail.9. An endoscope apparatus for endoscopic treatment, the apparatuscomprising: an endoscopic insertion tube having at least oneillumination channel and at least one viewing channel and not having aworking channel capable of introducing an endoscopic instrumenttherethrough, and comprising an outer surface formed into at least oneouter rail, the outer rail formed longitudinally thereon and extendingalong a portion of the insertion tube, the outer rail having a firstpredetermined shape; at least one medical device having a proximal endand extending to a distal end, the medical device having including anouter wall having at least one mounting unit having a mounting unitlength formed thereon and extending from a proximal portion of the outerwall to the distal end of the medical device, the mounting unit having asecond predetermined shape cooperable with the first predeterminedshape; the second predetermined shape formed to complement and slidablycooperate with the first predetermined shape of the outer rail forslidably attaching the medical device thereto; and wherein each mountingunit is formed with increased prominence from the proximal portion tothe distal end, a diameter of the at least one mounting unit proximallyand gradually decreasing longitudinally along the outer wall of the atleast one medical device to engage the outer rail.
 10. The apparatus ofclaim 9 wherein the at least one outer rail comprises first and secondouter rails formed on the outer surface.
 11. The apparatus of claim 10wherein the at least one medical device comprises first and secondmedical devices, each having mounting units formed thereon andconfigured to mate with one of the first and second outer rails.
 12. Theapparatus of claim 9 wherein the insertion tube comprises a proximal endand a distal end, the at least one outer rail being formed on theinsertion tube from the proximal end to the distal end so that themedical device may be slidably introduced at the proximal end andadvanced beyond the distal end.
 13. The apparatus of claim 9 wherein thefirst predetermined shape has two grooves, the second predeterminedshape being cooperable with the two grooves of the first predeterminedshape.
 14. The apparatus of claim 9 wherein the at least one outer railproximally tapers longitudinally along the outer surface of theinsertion tube to receive the mounting unit.
 15. The apparatus of claim11 wherein the at least one outer rail proximally tapers longitudinallyalong the outer surface of the insertion tube to receive the mountingunit.
 16. The apparatus of claim 12 wherein the at least one outer railproximally tapers longitudinally along the outer surface of theinsertion tube to receive the mounting unit.
 17. An endoscope apparatusfor endoscopic treatment, the apparatus comprising: an endoscopicinsertion tube having at least one illumination channel and at least oneviewing channel and not having a working channel capable of introducingan endoscopic instrument therethrough, and comprising an outer surfaceformed into a plurality of outer rails, the plurality of outer railsformed longitudinally and extending along a portion of the insertiontube, the plurality of outer rails having a first predetermined shape;at least one medical device including an outer wall having at least onemounting unit formed thereon along a portion of a length of the outerwall, the mounting unit having a second predetermined shape cooperablewith the first predetermined shape; the second predetermined shapeformed to complement and slidably cooperate with the first predeterminedshape of the outer rail for slidably attaching the medical devicethereto; and wherein the first predetermined shape has at least twogrooves, each groove being located between two adjacent outer rails, thesecond predetermined shape being cooperable with the at least twogrooves of the first predetermined shape, each outer rail being formedwith increased prominence distally, a diameter of the at least one outerrail comprising the outer surface of the endoscopic insertion tubeproximally and gradually decreasing longitudinally to receive themounting unit, the mounting unit having at least one element which makesdirect contact with two adjacent outer rails when the endoscopicinsertion tube and the medical device are in slidable connection. 18.The apparatus of claim 17 wherein the plurality of outer rails comprisesfirst and second outer rails formed on the outer surface.
 19. Theapparatus of claim 17 wherein the insertion tube comprises a proximalend and a distal end, the at least one outer rail being formed on theinsertion tube from the proximal end to the distal end so that themedical device may be slidably introduced at the proximal end andadvanced beyond the distal end.